Azithromycin versus placebo in acute infectious rhinitis with clinical symptoms but without radiological signs of maxillary sinusitis.

In this double-blind, parallel-group, multicenter study, 169 patients with symptoms of maxillary sinusitis but without radiographically confirmed empyema (pus) were randomly assigned to receive either 500 mg azithromycin once daily for 3 days (87 patients) or placebo daily for 3 days (82 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 31% in the placebo group; after 25 days the cure rate was 79% versus 67%, respectively. When both cure and improvement were considered, the corresponding figures after day 25 were 90% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 24 (27%) of the azithromycin-treated patients and in 15 (18%) of those treated with placebo, but the difference was not statistically significant. There was a difference in efficacy in favor of azithromycin in the treatment of rhinitis with symptoms of maxillary sinusitis but without radiological signs of empyema (pus). Antibiotics should only be used to alleviate symptoms in patients with moderate to severe symptoms, as the results after 25 days for both improvement and cure are equal. In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema, treatment with azithromycin seems to result in a better cure rate after 10-12 days when compared with placebo.

A multicentre (double-blind) comparative study to assess the safety and efficacy of fluconazole and griseofulvin in the treatment of tinea corporis and tinea cruris.

In a double-blind, parallel group study we compared fluconazole 150 mg once weekly with griseofulvin 500 mg once daily for 4-6 weeks in the treatment of tinea corporis or tinea cruris. Eighty-four of 114 patients (74%) (39% after 3 weeks) were clinically cured in the fluconazole group compared with 72 of 116 (62%) (39% after 3 weeks) in the griseofulvin group (P = 0.06). In the fluconazole group 78% were mycological cured compared with 80% in the griseofulvin group. In the fluconazole group nine patients (7.5%) had treatment related adverse events and in the griseofulvin group 15 patients (12.5%) had adverse events. Fluconazole 150 mg once weekly for 6 weeks is both clinically and mycologically effective in the treatment of tinea corporis and tinea cruris and few side-effects were reported.

Efficacy and safety of azithromycin versus phenoxymethylpenicillin in the treatment of acute maxillary sinusitis.

In the treatment of acute maxillary sinusitis, azithromycin offers an advantage over phenoxymethylpenicillin in that a complete course of treatment requires drug administration once daily for only three days. In this double-blind, parallel-group, multicenter study, 438 patients with radiographically verified maxillary sinusitis were randomly assigned to receive either 500 mg azithromycin once daily for three days (221 patients) or 1.3 g phenoxymethylpenicillin three times daily for ten days (217 patients). Nasal secretion, maxillary tenderness and pain, nasal obstruction, general malaise, and hyposmia, were assessed at the start of the study and on days 4, 11, and 25 of treatment. After 11 days 58% of the patients in the azithromycin group were cured versus 51% in the penicillin group; after 25 days the cure rate was 79% versus 76%, respectively. When both cure and improvement were considered, the corresponding figures after 11 days were 97% (azithromycin) and 95% (penicillin); after 25 days they were 92% and 88%, respectively. Adverse events, predominantly gastrointestinal, occurred in 73 (33%) of the azithromycin-treated patients and in 87 (40.1%) of those treated with penicillin. No difference in efficacy was found between the two drugs in the treatment of acute maxillary sinusitis, and the adverse effects were comparable. The short duration of treatment with azithromycin offers a significant advantage over treatment with phenoxymethylpenicillin.

Adverse reactions following two separate intravascular injections of contrast media in the same patient. A comparison between iohexol and monomeric ionic media.

Adverse reactions following contrast medium injections in 26 non-comparative and parallel trials were extracted from the iohexol vascular clinical trial program in Northern Europe. Six hundred and forty-one patients (13-88 years old) in whom information was available about a vascular contrast medium examination before the iohexol clinical trials were included, enabling a retrospective within patient comparison of adverse reactions. Iohexol gave a lower recurrence frequency (approximately 3.5 times) of reactions than ionic monomers in patients who previously experienced adverse reactions to vascular contrast media. In order to overcome some of the drawbacks with the present retrospective design, prospective comparative studies are recommended.